Various forms of psychotherapies have been shown to be efficacious and cost-effective for a wide spectrum of mental disorders. Concerns have been raised about the generalisability of the findings from randomised controlled psychotherapy trials since the conditions and characteristics of such efficacy trials differ significantly from routine clinical practice.
Behavioural interventions, and in particular disorder-specific psychotherapy techniques, differ in their complex nature in many ways from the classic application of double-blind RCTs seen in drug trials. In addition, studies with adaptive designs and interventions will be playing a more prominent role in the future considering the relevance of providing individualised and precision therapy.
In this context, it is particularly relevant when the supposed control condition is significantly more successful than the actual experimental psychotherapeutic intervention. One specific explanation, it might be that the experimental treatment entails adverse effects. However, this can also happen under active control conditions, which are particularly close to the mechanisms of action of the disorder and sometimes include additional optimisation of the therapy according to current guidelines. Another aspect which might contribute to the control condition being is the choice and the assessment of the primary outcome that can be very challenging in the field of mental health where there is often no clear biomarker or ‘objective’ measure available and that disorders might be characterised by different key symptoms. This may lead to circumstances in which a trial turns out ‘negative’ on an outcome which has been chosen more or less arbitrarily from different potential equivalent outcomes.
Authors concluded stating that dedicated effort is needed for conducting state-of-the-art trials to assess psychological therapies and inform policy and practice. Accordingly, the design and conduct of these trials warrants scrutiny and quality improvement. An important factor is the selection of an adequate and suitable control condition. This is especially the case for the complex interplay of active and confounding components within digitally enhanced psychotherapeutic interventions. Clinical researchers should be trained even better and earlier in this growing aspect of clinical research. Meanwhile, models for such systematic training have been tested and proven.
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